Pharmaceutical Technology, Apr 2, 2013 - Pharmaceutical Technology

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Pharmaceutical Technology, Apr 2, 2013
Cover Story
Process Analytical Technology and Process Control in Solid-Dosage Manufacturing
By Jennifer Markarian
Industry is moving toward closed-loop control of continuous processing.
Ensuring Sterility of Parenteral Products
By Adeline Siew, PhD
Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.
Special Report
Evaluating Equipment Utility and Innovation
By Jennifer Markarian
A Pharmaceutical Technology survey shows satisfaction with utility and innovation in most solid dosage and parenteral drug-manufacturing equipment.
Packaging Forum
Previewing Packaging Innovations
By Hallie Forcinio
The annual INTERPHEX show presents end-to-end packaging solutions.
API Synthesis and Manufacturing
Advancing Flow Chemistry in API Manufacturing
By Patricia Van Arnum
Continuous flow chemistry offers potential for greater control, improved safety and environmental profiles, and efficient chemical transformations.
Peer-Reviewed Research
Method Validation by Design to Support Formulation Development
By Mark Alasandro , Thomas A. Little , Jeffrey Fleitman
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.
Miniaturization of a Simulated Gastric Fluid Dispersion Experiment On a Microfluidics System
By Nicole L. Hill , Todd Nelson , Elizabeth Kwong , Tim Rhodes , Brian Farrer , Allen C. Templeton
The miniaturization of preclinical safety assessment studies using a microfluidic chip system and optical microscopy can help reduce compound requirements, time, and costs in formulation development.
Regulatory Watch
Advancing QbD in the EU
By Sean Milmo
The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.
Manufacturers Under Pressure to Manage Painkillers
By Jill Wechsler
Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.
Regulation & Compliance
Trends in GMP Violations
FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year.
Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards
By Hong Wang , Catherine Sheehan , Lawrence H. Block , Richard C. Moreton , Richard H. Wendt , Shireesh P. Apte , Eric J. Munson
This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.
Regulatory Roundup
By Jill Wechsler
Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.
Global Feature
Report from Latin America
By Jill E. Sackman
Latin America's diverse growing market seeks regulatory harmonization.
Report from Russia
By Vadim Konyushkevich , Ksenia Stepanischeva
Strengthening government control or striving for compliance with international standards?
Report from Thailand
By Jane Wan
The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.
Inside USP
Moisture Permeation of Pharmaceutical Packaging
By Desmond Hunt
USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.
Inside EDQM
The Need for Pharmacopeial Harmonization
By Susanne Keitel
In the context of international trade, the need to develop global quality standards for medicines is increasing.
Ingredients Insider
Fine-Chemical Producers Make Targeted Investments
By Patricia Van Arnum
Contract API manufacturers proceed with select investment in capacity and service additions.
Bio/Pharmaceutical Facility Design and Operation: A Primer
A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training
Outsourcing Outlook
Strategic Partnering for Manufacturing
By Jim Miller
Eisai and Biogen Idec pursue an innovative approach to capacity management.
Viral Vaccine Manufacturing
A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.
Statistical Solutions
Rounding Results for Comparison with Specification
By Chris Burgess
The mysteries of rounding are exposed; strict, unbiased rounding can be applied.
Ask the Expert
The Affect of FDASIA on Inspections
David Elder, vice-president, technical at PAREXEL, discusses US legislation allows for inspection of generic-drug activities.
Guest Editorial
INTERPHEX 2013: Aligning with Industry's Needs
Conference and exhibits provide a meeting place for professionals to exchange ideas.
Prescribing Caution for Biosimilars
By James C. Greenwood
Sound policies are needed to govern the substitution of interchangeable biologics.


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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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